FDA announces proposed deeming regulation – Conference call at 2:00 EST today!
Thursday, April 24, 2014
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Posted by: Natalia Gromov
Dear Colleagues,
This morning, FDA released its proposed deeming rule on regulation of tobacco
products (including e-cigarettes). FDA will be convening a conference call at 2
pm EST today to present its official statement and answer questions. To
participate in the conference call, use the call-in information below:
For participants in the United States or Canada: 866-844-9416
All others should dial 1-203-369-5026.
The passcode for all callers, which will be asked for orally, is "CTP.”
A replay will be available beginning one hour after the briefing until May 8,
2014. To listen to the replay, call 866-415-3310. The passcode for all callers
is "CTP.”
Although we have not yet had time to review the full document, highlights
include: (1) companies
would have to apply for FDA product approval (but have 2 years after rules are
finalized to do so, and can keep their products on the market in the interim
and importantly continue to bring new products to market); (2) no free samples of
e-cig products; (3)
ban on the sale of the devices to anyone below age of 18; (4) no health claims
in any advertising; (5) requiring
manufacturers to register with the FDA and list the ingredients in their
products (not clear yet if these ingredients will be required to be listed on
products); (6)
requiring a warning label stating that nicotine is addictive (which would have
to be added no later than 2 years after the rule is finalized). The proposal did NOT include:
(1) restrictions
of flavors (although it has been suggested this could be re-evaluated at a
later time); (2)
a ban on internet sales to adults; (3)
a ban on TV advertising. FDA cannot
enact a federal tax on e-vapor products or ban internet sales as these would
fall under the realm of Congress.
Now that the proposed regs are published, there is a 75-day comment period,
after which the FDA will review the comments, eventually issuing a final rule
which must be reviewed by the OMB before being enacted. The process is likely
to take 12-24 months before final regulations are implemented given the
rulemaking process though some items will need to be complied with immediately.
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